NCT05450042|UnknownFDA Device
Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation
Scientific Proposal to Substantiate Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation
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Scientific Proposal to Substantiate Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation
Sponsor study identifier
interventional
70
1 country
1
Study Start
April 6, 2022
Actual (reported)Primary Completion
April 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Endovascular treatment of symptomatic atherosclerotic peripheral artery disease (PAD) is recommended as the primary revascularization strategy. Percutaneous transluminal angioplasty (PTA) of the superficial femoral artery has a high initial success rate, but restenosis and dissections frequently occur.The influence of the novel devices with improved hemodynamic capabilities with respect to vasomotion of the vessel wall, vascular function and vascular compliance can be measured by FMD (flow-mediated dilation), arterial stiffness indices and vascular strain analysis. The aim of this ITT is to determine the potential improvement and impact of the SELUTION SLR in the infrainguinal arteries on local vascular function.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 6, 2022
Actual (reported)June 2, 2022
Actual (reported)July 8, 2022
Actual (reported)April 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery
1 month
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery
6 months
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery
Sustained Limus Release drug eluting balloon
Conventional: Medtronic INpact
Sirolimus DCB
Paclitaxel DCB
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Essen, Clinic of Cardiology and Angiology
Essen, North Rhine-Westphalia, 45147, Germany
Rammos C, Petrikhovich O, Akan B, Sacirovic M, Lortz J, Fakea S, Knuschke R, Messiha D, Rassaf T. Sirolimus Versus Paclitaxel Drug-Coated Ballons for Femoropopliteal Disease: The LIMUS FLOW Trial. J Am Heart Assoc. 2026 Sep 29:e046944. doi: 10.1161/JAHA.125.046944. Online ahead of print.
Christos Rammos, Professor
University Hospital, Essen
First Submitted
June 2, 2022
First Posted
July 8, 2022
Study Start
April 6, 2022
Actual (reported)Primary Completion
April 6, 2024
Estimated (date passed)EVERO Drug-coated Balloon (DCB) Randomized Trial
12 months
Changes in pulse wave velocity (PWV)
Baseline, followed at 1, 6 and 12 months
Changes in augmentation index
Baseline, followed at 1, 6 and 12 months
Changes in vascular strain
Baseline, followed at 1, 6 and 12 months
Changes in peripheral perfusion determined by ABI (ankle brachial index)
Baseline, followed at 1, 6 and 12 months
Primary patency (PP) of target lesion
Baseline, followed at 1, 6 and 12 months
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 6, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 5, 2023
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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